Surgical Methods for Uterine Septum

Overseen By Sarah L Rodriguez, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Blood thinners

Disqualifiers: Tubal disease, Bleeding diastasis, Fibroids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: During the surgery

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical methods for removing a uterine septum, a tissue wall that divides the uterus and can lead to complications like infertility or miscarriages. One method, hysteroscopic septoplasty utilizing bipolar electrosurgery, uses electric tools, while the other employs scissors without electric tools. Researchers aim to determine which method is faster, safer, and less likely to require follow-up surgeries. Women with a confirmed uterine septum larger than 1 cm who have experienced related issues may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on blood thinners to participate.

What prior data suggests that these surgical methods are safe for uterine septum resection?

Research shows that performing hysteroscopic septoplasty with scissors, without electrical tools, is safe. Studies have found that this method can improve fertility for women. In one study, almost half of the women who had their uterine septum removed this way became pregnant, and most carried their pregnancies to term.

Hysteroscopic septoplasty using electrical tools, known as bipolar electrosurgery, is also widely used and generally considered safe. Both methods aim to fix the same problem, but this trial examines which one works better and has fewer side effects.

Overall, previous research indicates that both treatments are promising in terms of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical methods for uterine septum because they explore new approaches to an existing procedure. The first method utilizes bipolar electrosurgery, which is a standard approach but is being compared to a novel technique using hysteroscopic scissors without electrosurgery followed by morcellation. This scissors method could potentially offer a gentler, less invasive option, reducing tissue damage and improving recovery times. By comparing these two approaches, researchers hope to determine if the innovative scissors technique can provide similar or better outcomes with fewer side effects.

What evidence suggests that these surgical methods are effective for uterine septum resection?

Research has shown that using special scissors, rather than electrical tools, to remove a uterine septum can improve the chances of having a baby. One study found that almost half of the women who underwent this procedure became pregnant, and over 70% of those pregnancies resulted in a full-term birth. Other studies have also found higher pregnancy rates and fewer issues like miscarriage and early labor after the surgery. This trial will compare two methods: one group will undergo hysteroscopic septoplasty using bipolar electrosurgery, while another group will have the septum removed with hysteroscopic scissors without electrosurgery. Although various methods exist, using scissors is a promising option with good results for many women. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with a uterine septum, which is an extra piece of tissue in the uterus. Participants should not have any other health issues that could complicate surgery. The study aims to find out if removing this tissue without using electricity (electrosurgery) is better than the current method.

Inclusion Criteria

I am between 20 and 44 years old.

My MRI or 3D imaging shows a septum thicker than 1.0 cm.

Exclusion Criteria

I am not taking any blood thinners.

I do not have a laparoscopy planned.

I have a diagnosed condition affecting my fallopian tubes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hysteroscopic septoplasty using either bipolar electrosurgery or scissors without electrosurgery

During the surgery

Follow-up

Participants have a routine follow-up visit to assess septum resolution and potential need for additional procedures

4 weeks

1 visit (in-person)

Post-operative Monitoring

Participants' recovery and satisfaction are assessed with follow-up phone calls

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Hysteroscopic septoplasty utilizing bipolar electrosurgery
• Removal of uterine septum with hysteroscopic scissors without electrosurgery

Trial Overview The study compares two surgical methods for treating a uterine septum: one uses scissors without electrosurgery and the other uses bipolar electrosurgery. It will look at how long the surgery takes, what complications might occur, and whether additional procedures are needed afterwards.

How Is the Trial Designed?

Group I: Study Intervention B (study group) Experimental Treatment 1 Intervention

Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue

Group II: Study Intervention A (control group) Active Control 1 Intervention

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Hysteroscopic septoplasty utilizing bipolar electrosurgery is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Hysteroscopic septoplasty for:

• Uterine septum
• Infertility
• Abnormal uterine bleeding

Approved in United States as Hysteroscopic septoplasty for:

• Uterine septum
• Infertility
• Abnormal uterine bleeding
• Recurrent miscarriage

Approved in Canada as Hysteroscopic septoplasty for:

• Uterine septum
• Infertility
• Abnormal uterine bleeding

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

Hysteroscopic metroplasty, a minimally invasive surgical technique, was successfully performed on 11 patients with septate uterus, showing good surgical outcomes without any intra- or postoperative complications.

The initial results suggest that if pregnancy outcomes improve as expected, hysteroscopic metroplasty could replace traditional abdominal surgery as the preferred treatment for uterine septa, potentially reducing recovery time and risks associated with more invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hysteroscopic treatment of uterine septa. Perino, A., Cittadini, E., Hamou, J., et al.[2004]

Hysteroscopic metroplasty significantly improved reproductive outcomes in women with a septate uterus, with live birth rates increasing from 3.7% to 84.6% after surgery, and clinical pregnancy rates rising from 69.5% to 78.2%.

Factors such as age (≥ 35 years) and primary infertility were identified as independent risk factors negatively affecting postoperative clinical and ongoing pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproductive outcomes and risk factors of women with septate uterus after hysteroscopic metroplasty. Chang, Y., Shen, M., Wang, S., et al.[2023]

In a study involving 10 women with complete septate uterus, the technique of incising the cervical septum under hysteroscopic guidance was found to be simple, rapid, and safe, with an average procedure time of 24 minutes and no significant intraoperative bleeding.

Postoperative follow-up showed that all patients had competent cervices and did not experience any second-trimester abortions or premature deliveries, indicating that this technique is effective and does not lead to major obstetric complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metroplasty for the complete septate uterus: does cervical sparing matter? Vercellini, P., De Giorgi, O., Cortesi, I., et al.[2019]

Sectioning the cervical septum during hysteroscopic metroplasty significantly reduces operating time and the amount of distending media used, making the procedure safer and easier compared to preserving the cervical septum.

The study found that while there were some complications, such as significant bleeding in the group that preserved the cervical septum, there were no significant differences in reproductive outcomes between the two groups, suggesting that resection is a viable option for women with a complete uterine septum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hysteroscopic metroplasty of the complete uterine septum, duplicate cervix, and vaginal septum. Parsanezhad, ME., Alborzi, S., Zarei, A., et al.[2006]

Complicated hysteroscopic metroplasty can lead to acute uterine rupture during pregnancy and labor, highlighting the need for careful monitoring of patients who have undergone this procedure.

Ultrasound is an effective tool for detecting uterine lesions, which could help in managing labor more safely, especially in cases where prostaglandin (PGE2) is contraindicated after such surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uterine rupture after hysteroscopic metroplasty and labor induction. A case report. Gabriele, A., Zanetta, G., Pasta, F., et al.[2016]

Hysteroscopic metroplasty, a procedure to improve pregnancy outcomes for women with a uterine septum, carries a risk of uterine rupture during subsequent pregnancies, as demonstrated by a case of a patient experiencing this complication at 28 weeks.

Despite being rare, the occurrence of uterine rupture after this procedure highlights the need for patients to be informed about this potential risk in future pregnancies, although strategies to prevent such complications remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous uterine rupture with amniotic sac protrusion at 28 weeks subsequent to previous hysteroscopic metroplasty. Conturso, R., Redaelli, L., Pasini, A., et al.[2019]

Hysteroscopic metroplasty is the gold standard treatment for uterine septa, which affects about 1% of infertile women and 3.3% of those with repeated fetal losses, offering a low-morbidity option for correction.

While complications from the procedure are rare, there is a potential risk of uterine rupture following the resection of a uterine septum, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Septate uterus: role of hysteroscopic metroplasty]. Lourdel, E., Cabry-Goubet, R., Merviel, P., et al.[2007]

Hysteroscopic septoplasty is an effective procedure for treating a septate uterus, particularly beneficial for women with recurrent pregnancy losses, potentially improving live birth rates.

While enlarging hysteroscopic metroplasty shows promise in enhancing obstetrical outcomes for certain uterine malformations, evidence is insufficient to recommend it as a first-line treatment except in specific cases, such as older women or prior to assisted reproductive techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Do hysteroscopic metroplasties really improve really reproductive outcome?]. Garbin, O., Ziane, A., Castaigne, V., et al.[2013]

In a review of 125 patients, hysteroscopic septoplasty using scissors resulted in a higher pregnancy rate (88.8%) compared to the resectoscope (75.6%), but this difference was not statistically significant.

Overall, there were no significant differences in reproductive outcomes, including delivery rates and miscarriage rates, between the two techniques, indicating that both methods are similarly effective for treating a septate uterus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproductive outcome after operative hysteroscopy for uterine septum: scissors or diathermy? Daniilidis, A., Kalpatsanidis, A., Kalkan, U., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10683958/

Evaluation of the Success of Hysteroscopic Uterine Septum ... Eighteen (47.36%) of the patients who underwent uterine septum resection achieved pregnancy, and thirteen of these pregnancies were (72.2%) term pregnancies, ...

2. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07460-z

Reproductive outcomes following hysteroscopic uterine ... Some studies have reported improved pregnancy rates, live birth rates, and reductions in miscarriage, preterm labor, and ectopic pregnancy ...

3. asrm.org asrm.org/practice-guidance/practice-committee-documents/evidence-based-diagnosis-and-treatment-for-uterine-septum-a-guideline-2024/

Evidence-based diagnosis and treatment for uterine septum This guideline provides evidence-based recommendations regarding the diagnosis and effectiveness of surgical treatment of a uterine septum.

4. fertstert.org fertstert.org/article/S0015-0282(21)02039-2/fulltext

Hysteroscopic septoplasty: many techniques, little evidence Hysteroscopic incision of the incomplete uterine septum using 5-French scissors with marking strategies: a modified hysteroscopic technique

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211525003665

Surgical and reproductive outcomes of hysteroscopic ... Reproductive outcomes were available for 66 (65.3 %) patients and there were no significant differences in reproductive outcomes between patients with and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11930492/

Safety and effectiveness of office hysteroscopic metroplasty ... In conclusion, office-based hysteroscopic removal of uterine septum is a safe and effective intervention to improve fertility outcomes for ...